DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, Claims 16-23, drawn to methods of assembling a sub-assembly of a medicament delivery device.
Group II, Claims 24-30, drawn to syringe carriers for a medicament delivery device, and a medicament deliver device.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons.
Groups I and II lack unity of invention because the groups do not share the same or corresponding technical feature; that is, there is no overlap in subject matter between the bodies of Claims 16 and 24.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
During a telephone conversation with Jordan Pringle on 15 January 2026, a provisional election was made without traverse to prosecute the invention of Group I, Claims 16-23. Affirmation of this election must be made by applicant in replying to this Office action. Claims 24-30 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the combined steps of Claim 16 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: Method of rotating a syringe relative to a carrier in a medicament delivery device
The Abstract of the Disclosure (“Abstract”) is objected to because: it is too long (156 words); and it includes self-evident terms (“this application describes” in line 1, “are described” in line 2. A corrected Abstract is required. See MPEP § 608.01(b). Any replacement Abstract must commence on a separate sheet, apart from any other text, 37 C.F.R. §§ 1.52(b)(4), 1.72(b), and include markings to show added and deleted text, 37 C.F.R. § 1.121(b)(2).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17-19, 21, and 23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In each of Claims 17-19, line 1 of each claim, “is inserted” renders the scope of the claim indefinite, because it is unclear if the clause introduces a new manipulative step, or is a further limitation of an “inserting” step of Claim 16 (which is how the claim has been treated).
In Claim 21, line 1, “is moved” renders the scope of the claim indefinite, because it is unclear if the clause introduces a new manipulative step, or is a further limitation of an “inserting” step of Claim 16 (which is how the claim has been treated).
In Claim 23, line 2, “is connected” renders the scope of the claim indefinite, because it is unclear if the clause introduces a new manipulative step, or is a structural feature of the sub-assembly before the steps of Claim 16 are performed (which is how the claim has been treated).
The Examiner suggests redrafting each of the foregoing claims using Claim 20 as a template, i.e., referencing a previously recited manipulative step and stating that the further limitation of the claim is a modification of that step.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 16-23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 20140330213, by Hourmand et al. (“Hourmand”), in view of U.S. Patent App. Pub. No. 20170319788, by Morris et al. (“Morris”).
Hourmand describes a device substantially as claimed by Applicant, as follows.
Claim 16: A method of assembling a sub-assembly of a medicament delivery device (Figs. 27 and 28), the method comprising the steps of:
providing a syringe carrier (1, 1.1) and a syringe (2, 2.1);
inserting the syringe into the syringe carrier in the longitudinal direction (comparing Figs. 27 and 28, the syringe has been inserted into the carrier),
While Hourmand states that its syringe carrier and syringe are to be used in a “medicament delivery device” ([0003]), it oddly does not describe the exact nature of that device, and thus that it includes a housing that extends in a longitudinal direction along a longitudinal axis from a proximal end to a distal end; or, a step of inserting the syringe carrier into the housing so that the syringe carrier is aligned with the housing along the longitudinal axis.
Morris relates to syringe-based medicament delivery devices, as does Hourmand, and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Morris teaches that Sanofi’s drug delivery devices, such as that described by Hourmand, can be constructed to include a syringe (6) contained within a syringe carrier (14), with the carrier being coaxial along a longitudinal axis of a housing (11; see Fig. 5, for example) from a proximal end (right end in Fig. 5) to a distal end (left end in Fig. 5), and thus also discloses the manipulative step of inserting the syringe carrier into the housing so that the syringe carrier is aligned with the housing along the longitudinal axis, so that syringe can be used to dispense the medication and the alignment of the components is maintained for that process.
It would have been obvious, before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains, to use Hourmand’s Sanofi syringe-and-carrier with a medicament delivery device having a housing that extends in a longitudinal direction along a longitudinal axis from a proximal end to a distal end, and performing a step of inserting the syringe carrier into the housing, because Morris teaches that Sanofi’s drug delivery devices have housings used with syringe carriers and syringes which are aligned along a longitudinal axis of the housing, so that syringe can be used to dispense the medication and the alignment of the components is maintained for that process.
Claim 16 also requires the steps of:
(a) the syringe carrier remains aligned with the longitudinal axis during insertion of the syringe into the syringe carrier; and
(b) as the syringe is inserted into the syringe carrier, the syringe rotates from a first position parallel to the longitudinal axis to a second position that is not parallel to the longitudinal axis and then to a third position parallel to the longitudinal axis.
Concerning (a), in order to automate the process of constructing a Hourmand-Morris device with a minimum of damaged components and rework, a person of ordinary skill in the art would immediately understand that there are only two options for the order of operation in the workflow of assembling such a device: the syringe is inserted into the carrier after the carrier is inserted into the housing; or before. As the Examiner immediately envisages both of these options, it would have been obvious, before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains, to insert the syringe into the carrier after the carrier is inserted into the housing in a Hourmand-Morris device, and thus, as the syringe carrier is, prior to the syringe insertion, already aligned with the housing’s longitudinal axis, maintain the alignment of the carrier and housing during insertion of the syringe into the syringe carrier in order to limit the variability in the assembly process.
Concerning (b), during manual assembly of the syringe into the syringe carrier described by Hourmand, the lip 1.4 at the distal end of the carrier (Fig. 27) presents an obstruction to the full insertion of the syringe, to arrive at the configuration of Fig. 28. Thus, as a person inserts the syringe 2 into the carrier 1, in order to clear the lip 1.4, the person would know to ‘wiggle’ the syringe relative to the carrier, so that the tip of cap 4 clears the lip, as it is a very commonplace practice when fitting together any two subcomponents of a device in order to align them. Such ‘wiggling’ will include positions of the syringe, relative to the carrier, at which: the syringe axis and the carrier axis are first aligned (e.g., when the cap 4 enters the proximal end at 1.18; “first position”); the syringe is then wiggled (after the cap 4 abuts the lip 1.14; “second position”); and, the syringe axis and the carrier axis are again aligned (e.g., when the cap 4 has fully cleared the lip 1.14 and is in the configuration of Fig. 28; “third position”).
Accordingly, it would have been obvious, before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains, during assembly of a Hourmand-Morris device, as the syringe is inserted into the syringe carrier, rotate the syringe from a first position parallel to the longitudinal axis to a second position that is not parallel to the longitudinal axis and then to a third position parallel to the longitudinal axis, because wiggling two subcomponents relative to each other in order to align them during assembly is a commonplace practice, and it would be necessary to wiggle Hourmand’s syringe relative to its carrier it order for its cap to clear the distal end lip of its carrier, in order to complete their assembly.
Claim 17: (The method of claim 16,) wherein the syringe carrier is inserted into the housing before the syringe is inserted into the syringe carrier (see treatment and discussion above).
Claim 18: (The method of claim 16,) wherein the syringe carrier is inserted into the distal end of the housing (see treatment above; Morris, Fig. 5, because of the complicated plunger drive subcomponents proximal of the carrier, insertion into the distal end of the housing, where the carrier is finally located anyway, simplifies assembly of the entire device.).
Claim 19: (The method of claim 16,) wherein the syringe is inserted into a distal end of the syringe carrier (when Hourmand’s cap 4 passes the lip 1.14, the syringe is inserted into the distal end of its carrier).
Claim 20: (The method of claim 16,) wherein the step of inserting the syringe carrier into the housing comprises inserting the syringe carrier into a distal position in the housing (Morris, Fig. 5), and wherein the syringe carrier is subsequently moved in the proximal direction relative to the housing to a proximal position in the housing (in order to latch Morris’s carrier 14 to the housing, noting in Fig. 3 the detent-and-groove under the lead line of ref. no. 7, and the bayonet fitting just proximal of those structures, the carrier 14 would have to be first positioned in a distal position and then pushed proximally to seat the carrier in the housing).
Claim 21: (The method of claim 20,) wherein the syringe is moved with the syringe carrier from the distal position to the proximal position (see treatment and discussion above).
Claim 22: (The method of claim 16,) wherein when the syringe is in the third position, a shoulder of the syringe (Hourmand, Fig. 26, at 7) abuts a protrusion of the syringe carrier (Hourmand, lip 1.14).
Claim 23: (A method of assembling a medicament delivery device comprising the method according to claim 16,) wherein the sub-assembly is connected to a cap (Hourmand, cap 4).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent App. Pub. No. 2014/0128841 describes a syringe and carrier which requires rotation of the two relative to each other for assembly,
The balance of the documents cited with this Office Action relate generally to syringe carriers and medicament delivery devices including them.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783